This study is to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single tablet regimen (STR) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents. Safety, tolerability, and efficacy will also be evaluated through Week 48.

A total of 50 adolescent participants (12 to < 18 years of age) will be enrolled to receive EVG/COBI/FTC/TDF as follows:

Part A: Twelve to 16 eligible participants will be enrolled to evaluate steady-state PK, and confirm the dose, with the intent to enroll at least 4 participants 12 to < 15 and at least 4 participants 15 to < 18 years of age.

Part B: Following confirmation of EVG exposure in at least 12 participants from Part A, 34 to 38 participants in addition to those enrolled in Part A will be enrolled to evaluate the safety, tolerability and antiviral activity of EVG/COBI/FTC/TDF STR.

For Part A, PK parameter of EVG as measured by Ctau and Cmax and PK parameter of emtricitabine (FTC), tenofovir (TFV), and cobicistat (COBI) as measured by AUCtau, Cmax, and Ctau [ Time Frame: Day 10 ] [ Designated as safety issue: No ]

Ctau is defined as the observed drug concentration at the end of the dosing interval

Cmax is defined as the maximum observed concentration of drug in plasma

AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval)

Parent or guardian able to give written informed consent prior to any screening evaluations and willing to comply with study requirements

Plasma HIV-1 RNA levels of ≥ 1,000 copies/mL

CD4+ cell count > 100 cells/µL

Weight ≥ 35 kg (77 lbs)

Screening genotype report must show sensitivity to FTC and TDF

Able to swallow oral tablets

Adequate renal function

Clinically normal ECG

Documented screening for active pulmonary tuberculosis per local standard of care within 6 months of a screening visit

Hepatic transaminases ≤ 5 x upper limit of normal

Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

Individuals with a positive Hepatitis B surface antigen screening test can participate in the study, providing that alternate therapy (other than TDF) for chronic Hepatitis B infection is available as a part of local standard of care

Adequate hematologic function

Negative serum pregnancy test for all females

Males and females of childbearing potential must agree to utilize highly effective contraception methods while on study treatment or agree to abstain from heterosexual intercourse throughout the study period and for 30 days following the last dose of study drug

Males must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 30 days following discontinuation of investigational medicinal product

Must be willing and able to comply with all study requirements

Life expectancy ≥ 1 year

Exclusion Criteria:

A new AIDS-defining condition diagnosed within the 30 days prior to screening

Prior treatment with any approved or investigational or experimental anti HIV-1 drug for any length of time (other than that given for prevention of mother-to-child transmission)

Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit

Have any serious or active medical or psychiatric illness which would interfere with treatment, assessment, or compliance with the protocol. This would include uncontrolled renal, cardiac, hematological, hepatic, pulmonary, endocrine, central nervous, gastrointestinal, vascular, metabolic, immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment within 30 days prior to the study dosing.

Current alcohol or substance abuse that will potentially interfere with compliance

Have history of significant drug sensitivity or drug allergy

Known hypersensitivity to the study drugs, the metabolites or formulation excipients

Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening or expected to receive these agents during the study

A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma

Have previously participated in an investigational trial involving administration of any investigational agent within 30 days prior to the study dosing

Participation in any other clinical trial without prior approval from sponsor is prohibited while participating in this trial

Receiving ongoing therapy with any disallowed medications, including drugs not to be used with EVG, COBI, FTC, TDF or individuals with any known allergies to the excipients of EVG/COBI/FTC/TDF STR tablets

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721109